Packaging for medical containers

ABSTRACT

Packaging for medical containers, including a tub having a peripheral wall, a sealing cover sealable on an opening of the tub and a sealing envelope able to protect the sealing cover. The sealing envelope includes: a lower sealing part, having a frame able to be sealed to the peripheral wall of the tub, and a bonding surface that extends outwards from the frame, and an upper sealing part sealed on the bonding surface to enclose the opening of the tub and the sealing cover.

This invention is directed to a packaging for medical containers suchas, for example, syringes or cartridges. Each container notablycomprises a cylindrical body, in particular tubular, and “upper surface”located at or near the proximal end of this cylindrical body. This uppersurface is generally formed by a flange that can be integrally formedwith the cylindrical body or that can be a separate piece mounted onthis body.

In the present text, the distal end of a component or of a device meansthe end furthest away from the hand of the user and the proximal endmeans the end closest to the hand of the user, when the component ordevice is in the use position, i.e. when the user is injecting amedicine contained in the container into his body or into anotherpatient's body. Similarly, in the present text, the terms “in the distaldirection” and “distally” mean in the direction of the injection of themedicine, and the terms “in the proximal direction” and “proximally”mean in the direction opposite to the direction of injection.

Often, the containers must be transported from one site to another, whenthey are manufactured in one site and filled in another site, or, lessfrequently, when they are manufactured and filled in the same site andmust be delivered, once filled, to another site.

For this transportation, the containers are usually put in a “globalpackaging” comprising a grouping tray or nest, hereinafter “nest”, apackaging tub, hereinafter “tub”, a sealing cover and a plastic bag,hereinafter “header bag” to insure the sterility. The combination of thenest, the tub and the sealing cover will be cited hereinafter as“packaging” while the tub will correspond to an empty tub.

The nest can have various shapes according to the type of containersreceived: it can comprise openings that can be or not coaxiallysurrounded by chimneys for receiving the cylindrical bodies of thecontainers with flanges, these flanges leaning on the upper ends of thechimneys. Alternatively, the nest can have specific openings forreceiving cartridges that would be in contact with the bottom of thetub. In another embodiment, the nest can have chimneys with closedbottoms for receiving containers without flanges; the nest can also bemade in a resilient material and have openings in which the containersare frictionally maintained. In the following description, the nestdescribed is the one with openings coaxially surrounded by chimneys forreceiving containers with flanges.

The tub includes a peripheral outer flange levelled with its upperopening, for the sealing of the sealing cover. In use, the nest isplaced into the tub which is sealed with a sealing cover and sterilised.Then, series of global packagings are stacked into a box, bottom up, forexample, a cardboard or a plastic box with an intermediate sheet placedbetween two series of global packagings, a series being defined as a rowof several global packagings.

The header bag can be a classical header bag (e.g. made of plasticincluding a porous part). Alternatively, the header bag can have areinforced part positioned in such manner that the header bag gets afunction of load spreader. This reinforced part can be interdependent ornot with the bag, it can be in moulded or thermoformed plastic, and itcan be placed inside or outside the header bag. This reinforced part canbe for example at least one thermoformed plastic plate placed inside thebag below and/or above the tub. This reinforced load spreader header bagprotects the containers packaged into the packaging.

When received at destination, the global packagings are extracted fromthe box and flipped bottom down, the header bag is open, the tub isextracted from the header bag and unsealed. Then, the nests areextracted therefrom and the containers can be filled and/or handled.

This existing packaging is satisfactory in general but presents somedrawbacks.

Indeed, the header bag has a significant risk of perforation duringtransportation, which creates a risk of contamination of the packaging.

Moreover, this bag is relatively bulky and therefore limits the numberof packaging that can be stacked in a single box.

In addition, due to its size, this header bag wrinkles and folds duringtransportation, which implies, when opening the packaging, an additionalstep of manually tensioning the edge thereof, intended to be cut by anautomatic machine.

The main purpose of this invention is to overcome these drawbacks.

The packaging concerned comprises, in a way known per se, a tub having aperipheral wall, a sealing cover sealable on an opening of the tub and asealing envelope adapted to protect the sealing cover againstperforation.

According to the invention, said sealing envelope comprises:

-   -   a lower sealing part, having        -   a frame adapted to be sealed to the peripheral wall of the            tub, and        -   a bonding surface that extends outwards from the frame, and    -   an upper sealing part sealed on said bonding surface to cover        the opening of the tub and said sealing cover.

In the present text, the terms “lower” and “upper” designate somethingthat is respectively “closer” and “farther” from the bottom of the tub.

Thus, the packaging, according to the invention, does not include aheader bag enclosing the whole tub but (i) a lower sealing part having aframe adapted to be sealed to the peripheral wall of the tub, thatcomprises a bonding surface, and (ii) an upper sealing part intended tobe sealed on said bonding surface of the lower sealing part. These twosealing parts, when sealed, enclose the opening of the tub and thesealing cover.

The sealing envelope, thus formed, has no risk of perforation duringtransportation, since the two lower and upper sealing parts are tightlybonded one to the other. This sealing envelope is moreover compact andsaves space in the box. In addition, the edges of said upper and lowersealing parts are relatively rigid because these parts are bonded one onthe other which does not implies, at the time of opening the packaging,an additional step of manually tensioning an opening edge.

The term “sealing” as used in the present description means any way oftightly joining two parts, e.g. bonding, stamping, gluing, heat-sealingor welding.

According to one possibility, said lower sealing part and upper sealingpart are independent from one another. Said upper sealing part is fixedto said lower sealing part once the latter is positioned on the tub.

Alternatively, said upper sealing part is connected to said lowersealing part and is movable with respect to the latter between a firstposition, in which it does not prevent from sealing the lower sealingpart on the lower part of the tub, and a second position in which it ismoved over said lower sealing part and is able to be sealed to saidlower sealing part.

Said frame of said lower sealing part could exhibit a non-planar shape,including a first peripheral portion adapted to surround the peripheralwall of the tub and to be sealed thereto, and a second peripheralportion in the shape of an outer flange, this outer flange beingextended outwards to form said bonding surface.

Preferably, however, the peripheral wall of the tub includes an outersealing flange around said opening, the lower sealing part having anopening allowing the insertion of the tub, and having an innerperipheral portion forming said frame, dedicated to be sealed to theinferior surface of said outer sealing flange, and an outer peripheralportion forming said bonding surface, extending around the outer edge ofthe outer sealing flange when said lower sealing part is sealed to saidinferior surface.

Said lower and upper sealing parts are preferably flat sheets. In thiscase, said lower sealing part and said upper sealing part are preferablyformed from a single piece of flat material and are connected oneanother through a folding edge.

Preferably, said lower sealing part and/or said upper sealing part aremade of a heat-sealable material, so that their mutual bonding can beachieved by heat sealing.

Preferably, said lower sealing part and/or said upper sealing part aremade of a heat sealable material, or are coated with a heat-sealablematerial, so that said lower sealing part is able to be heat-sealable tosaid outer sealing flange.

Otherwise, said lower sealing part and said upper sealing part can bemutually bonded with an adhesive.

Said upper sealing part can contain at least a window of permeable andporous material, permeable to a sterilization medium but not to theambient contamination.

Said permeable and porous material of the upper sealing part can beTyvek®.

The invention will be better understood and other characteristics andadvantages thereof will become evident, with reference to the attachedschematic drawings, representing, by way of non-limiting and notexhaustive examples, embodiments of the packaging.

FIG. 1 is a perspective view of an upper sealing part of a sealingenvelope included in the packaging according to a first embodiment;

FIG. 2 is a perspective view of a lower sealing part of a sealingenvelope also included in the packaging according to this firstembodiment;

FIG. 3 is a side cross-section view of a tub with the upper and lowersealing parts before bonding these upper and lower parts to this tub;

FIG. 4 is a view similar to FIG. 3, said lower sealing part being bondedto the tub;

FIG. 5 is a view similar to FIG. 4, said upper sealing part being bondedto the tub and to the lower sealing part;

FIG. 6 is an enlarged, partial, side cross-section view of said upperand lower sealing parts according to a second embodiment, including atub before the bonding of the upper and lower sealing parts to this tub;

FIG. 7 is a view similar to FIG. 6 after the bonding of the upper andlower sealing parts to the tub; and

FIG. 8 is a perspective view of the sealing envelope similar to FIGS. 1and 2, according to a third embodiment.

FIGS. 3-5 show a packaging 1 for medical containers such as, forexample, syringes or cartridges, comprising a grouping tray or nest (notshown), hereinafter “nest”, a packaging tub 2, hereinafter “tub”, asealing cover 3 and a sealing envelope 4 formed by an upper sealing part4 a and a lower sealing part 4 b.

The nest comprises openings coaxially surrounded by chimneys forreceiving the cylindrical bodies of the containers, until the flangesthereof abut the upper ends of the chimneys. Such a nest is well knownand does not form part of the invention, so it is not particularlydescribed here. Reference can be made to the documents N° WO 03/089028or WO 02/40065, for example, in the name of the applicant, which showsuch nests.

As described on FIG. 3, the tub 2 is a container having a body 5 able tocontain the nest and the medical containers, which has an inner shoulder5 a for receiving the nest. The tub 2 has an upper peripheral wall 2 adelineating an upper opening 6 and including a peripheral outer flange 7levelled with this upper opening 6, for the sealing of the sealing cover3. The tub 2 is integrally formed by a single part of moulded plasticmaterial.

The sealing cover 3 is formed by a sheet of suitable heat sealablematerial, in particular by a sheet in Tyvek®, and is sealed on the upperperipheral wall 2 a or on the outer flange 7 of the tub 2 by heatwelding.

In reference to FIGS. 1 and 3, the upper sealing part 4 a of the sealingenvelope 4 is formed by a sheet of a material suited to protect thecover 3 against perforation and includes a window 8 made of a materialpermeable to a sterilization medium but not to the ambient contamination(this feature is well known in itself). This upper sealing part 4 a hasdimensions such that it is able to extend beyond the periphery of theouter edge of the flange 7 and to form, beyond the latter, a peripheralbonding surface designed to be bonded to the lower sealing part 4 b byheat welding.

The upper sealing part 4 a of the sealing envelope can be made of a flator a thermoformed sheet of a more or less rigid material (e.g. PET,HPDE, etc.).

In reference to FIGS. 2 and 3, the lower sealing part 4 b is formed by asheet of a material suited to protect the cover 3 against perforation.

For example, the lower sealing part 4 b can be made of a flat or athermoformed sheet of a material such as Tyvek®, HPDE, etc.

The desired stiffness of the upper and lower sealing parts can beadjusted by selecting an appropriate thickness for the sheet from whichthey are formed.

Said sealing part 4 b comprises a frame 4 b′ delineating a centralsquare or rectangular opening 9 and a bonding surface 4 b″ extendingoutwards, i.e. beyond the outer periphery of the frame 4 b′, forexample, in a direction that could be substantially parallel to that thedirection of the peripheral flange 7 and of the sealing cover 3. Thecentral opening 9 allows the lower sealing part 4 b to be insertedaround the body 5 of the tub 2 until reaching the inferior surface ofthe flange 7, and the frame 4 b′ is adapted to be sealed to thisinferior surface of the flange 7.

In use, the nest is placed in the tub 2 and the tub is sealed by thesealing cover 3. The lower sealing part 4 b is then inserted around thebody 5 and the frame 4 b′ thereof is bonded to the lower surface 7 a(shown on FIG. 3) of the flange 7 (FIG. 4); the upper sealing part 4 ais then sealingly bonded to the bonding surface 4 b″ of the lowersealing part 4 b (FIG. 5).

Thereafter, series of packagings 1 are stacked in boxes fortransportation.

According to the second embodiment shown on FIGS. 6 and 7, the upperperipheral wall 2 a of the tub 2 has no peripheral outer flange, and thesealing cover 3 is bonded to the upper edge of this peripheral wall 2 a.

The upper sealing part 4 a is similar to the one of the embodiment shownon FIGS. 3-5; it is formed of a sheet of a material suited to protectthe sealing cover from perforation.

In this embodiment, the lower sealing part 4 b exhibits a non-planarshape, wherein the frame 4 b′ is substantially parallel to theperipheral wall of the tub so as to surround the peripheral wall 2 a ofthe tub 2 and to be sealed thereto (by bonding, stamping, gluing,welding). Further, the bonding surface 4 b″ is substantiallyperpendicular to the frame 4 b′ and substantially parallel to thesealing cover 3 and adapted to be sealed on the upper sealing part 4 a.

According to the third embodiment shown on FIG. 8, said upper sealingpart 4 a is connected to said lower sealing part 4 b along a foldingline or edge 10. The upper sealing part 4 a is thus movable with respectto the lower sealing part 4 b between an unfolded position, in which itdoes not prevent from sealing the lower sealing part 4 b on the tub 2,and a folded position in which it is folded over said lower sealing part4 b and is able to be sealed to this lower sealing part 4 b.

As it has become clear from the foregoing, the invention provides apackaging for containers, in particular for syringes or cartridges,having, with respect to the packaging of the prior art, the determiningadvantages of:

-   -   having no risk of perforation during transportation, thanks to        the two upper and lower sealing parts 4 a, 4 b bonded one on the        other;    -   being compact and saving space in the box, and    -   providing rigid edges to the sealing envelope 4 thus avoiding an        additional step of manually tensioning an opening edge at the        time of opening the packaging.

The invention has been described above with reference to embodimentsgiven by way of an example. Of course, it is not limited to theseembodiments and extends to all other embodiments covered by the appendedclaims.

1. A packaging for medical containers, comprising a tub having a peripheral wall, a sealing cover sealable on an opening of the tub and a sealing envelope adapted to protect the sealing cover against perforation, wherein said sealing envelope comprises: a lower sealing part, having a frame adapted to be sealed to the peripheral wall of the tub, and a bonding surface that extends outwards from the frame, and an upper sealing part adapted to be sealed on said bonding surface to cover the opening of the tub and said sealing cover.
 2. The packaging of claim 1, wherein said lower sealing part and said upper sealing part are independent from one another.
 3. The packaging of claim 1, wherein said upper sealing part is connected to said lower sealing part and is movable with respect to the lower sealing part between a first position, in which it said upper sealing part does not prevent from sealing the lower sealing part on the tub, and a second position in which said upper sealing part is moved over said lower sealing part and is able to be sealed to said lower sealing part.
 4. The packaging of claim 1, wherein said lower sealing part exhibits a non-planar shape, wherein the frame is parallel to the peripheral wall of the tub so as to be adapted to surround the peripheral wall of the tub and to be sealed thereto, and the bonding surface extends outwards from the frame in a direction parallel to the sealing cover.
 5. The packaging of claim 1, wherein the peripheral wall of the tub includes an outer sealing flange around said opening of the tub, the lower sealing part having an opening for the insertion of the tub, and the opening of the lower having an inner peripheral portion forming said frame, the frame dedicated to be sealed to a lower surface of said outer sealing flange and having an outer peripheral portion forming said bonding surface, extending beyond an outer edge of the outer sealing flange when said lower sealing part is sealed to said inferior lower surface.
 6. The packaging of claim 1, wherein said lower and upper sealing parts are flat sheets.
 7. The packaging of claim 6, characterized in that said lower and upper sealing parts are formed from a single piece of flat material and are connected to one another through a folding edge.
 8. The packaging of claim 1, wherein said lower sealing part and/or said upper sealing part are made of a heat-sealable material, so that their mutual bonding can be achieved by heat sealing.
 9. The packaging of claim 5, wherein said lower sealing part and/or said upper sealing part are made of a heat sealable material, or are coated with a heat-sealable material, so that said lower sealing part is able to be heat sealed to said outer sealing flange.
 10. The packaging of claim 1, wherein said lower sealing part and said upper sealing part are mutually bonded with an adhesive.
 11. The packaging of claim 1, wherein said upper sealing part contains at least a window of permeable and porous material, permeable to a sterilization medium.
 12. The packaging of claim 11, wherein said permeable and porous material of the upper sealing part (4 a) comprises high-density polyethylene fibers.
 13. A packaging containing medical containers, comprising: a tub containing the medical containers, the tub having a peripheral wall, a sealing cover sealed on an opening of the tub and a sealing envelope adapted to protect the sealing cover against perforation, wherein said sealing envelope comprises: a lower sealing part, having a frame sealed to the peripheral wall of the tub, and a bonding surface that extends outwards from the frame, and an upper sealing part sealed on said bonding surface to cover the opening of the tub and said sealing cover.
 14. A method of packaging medical containers, comprising the steps of: placing the medical containers into a tub, the tub having a peripheral wall, and an opening, sealing the opening of the tub with a sealing cover, forming a sealing envelope adapted to protect the sealing cover against perforation, wherein said forming of the sealing envelope comprises: providing a lower sealing part having a frame adapted to be sealed to the peripheral wall of the tub, and a bonding surface that extends outwards from the frame sealing the frame on the peripheral wall of the tub, and sealing an upper sealing part on said bonding surface to cover the opening of the tub and said sealing cover. 